Ben Goldacre is once again arguing that pharmaceutical “industry-funded trials are too common, can’t be trusted — and bring pills to market that likely don’t work.” The NY Times features his argument today. He has exhaustively compiled problematic practices that add up to a shocking claim: “the entire evidence base for medicine has been undermined by a casual lack of transparency.” For example, here’s one vignette from his most recent book:
In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation — searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators — they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.
When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.
I have not come across a convincing industry or FDA response to Goldacre’s work. (I don’t find this brief letter particularly compelling.). He offers several case studies like the reboxetine one. Isn’t it time to fund systematic reviews of the evidence of effectiveness on all drugs?
A recent lawsuit against the FDA will test its usual trade secret rationale for failing to require drug companies to release all data from trials. If it succeeds, systematic reviews may be easier to complete, and will help save patients from the scourge of unnecessary or ineffective drugs. In the current information environment, perhaps the best hope we have is big data leading to more personalized comparisons of treatment effectiveness.
X-Posted: Concurring Opinions.
PS: A chart serendipitously found on the web:
Thanks for this post.
If there are any academic lawyers looking for a project, then this is fertile territory, especially around the flaws in legislation and codes of conduct for results sharing, enforcement flaws, and how systems vary around the world.
https://www.alltrials.net/wp-content/uploads/2013/01/Missing-trials-briefing-note.pdf
Dr Ben Goldacre
ben@badscience.net
http://www.badscience.net
Thanks for this post.
If there are any academic lawyers looking for a project, then this is fertile territory, especially around the flaws in legislation and codes of conduct for results sharing, enforcement flaws, and how systems vary around the world.
https://www.alltrials.net/wp-content/uploads/2013/01/Missing-trials-briefing-note.pdf
Dr Ben Goldacre
ben@badscience.net
http://www.badscience.net
If products launched by pharmaceutical companies which are tested through trials are no more than coated placebos, it will be imperative to halt such trials themselves. Risks are been taken if these trials end up in negative effects on the people being tested. Great article Ben
All these tests and results are relative, can’t expect a formal set for such tests. You only get to some sort of result through trial and error.
All these tests and results are relative, can’t expect a formal set for such tests. You only get to some sort of result through trial and error.
The whole purpose of trials is for one to use the result, to work on and improve on, its really disappointing to see, data being kept as a secret.
The whole purpose of trials is for one to use the result, to work on and improve on, its really disappointing to see, data being kept as a secret.
Great post and article. One way to address the issue is to require post-market observational trials for all approved products, and to predicate tort immunity (which is extensive in the US) on satisfactory fulfillment of post-market obligations and public disclosure of findings. I talk about how this might be set up in an article:
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1964025
Great post and article. One way to address the issue is to require post-market observational trials for all approved products, and to predicate tort immunity (which is extensive in the US) on satisfactory fulfillment of post-market obligations and public disclosure of findings. I talk about how this might be set up in an article:
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1964025
Great post and article. One way to address the issue is to require post-market observational trials for all approved products, and to predicate tort immunity (which is extensive in the US) on satisfactory fulfillment of post-market obligations and public disclosure of findings. I talk about how this might be set up in an article:
Great post and article. One way to address the issue is to require post-market observational trials for all approved products, and to predicate tort immunity (which is extensive in the US) on satisfactory fulfillment of post-market obligations and public disclosure of findings. I talk about how this might be set up in an article: